HAVE YOU OR A FAMILY MEMBER BEEN NEWLY DIAGNOSED WITH CROHN’S?

EXPLORER is a clinical research study designed to learn if a combination of 3 FDA-approved drugs—vedolizumab, adalimumab, and methotrexate—work when taken together in newly diagnosed patients who may be at a higher risk of disease related complications. The use of these drugs in this study is investigational.

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ABOUT CROHN’S DISEASE

Crohn’s disease belongs to a group of conditions known as Inflammatory Bowel Diseases (IBD). Crohn’s disease is considered a "chronic inflammatory" condition because it can cause periods of ongoing irritation of the digestive tract that directly cause symptoms, also called "flare-ups." These can be followed by periods of time when symptoms are not noticeable, also called "remission."

Approximately 780,000 people in the United States are affected by Crohn’s disease (CD). Women are slightly more likely to get CD than men. CD can occur at any age, but, diagnosis happens most to those between 15 and 35. It also appears that Crohn’s is growing more common in children and adults, and that being hospitalized due to Crohn’s is increasing.

ADDITIONAL STUDY INFORMATION

EXPLORER is a long-term clinical research study, which means the total amount of time you may be involved in the study is up to 132 weeks. It is also considered "open-label," which means both the study doctor and participants are aware of the medication being given.

The main goal of the study is to see if the combination of study drugs works on treating inflammation due to Crohn’s and future damage to the digestive system. Over time, Crohn’s is a progressive disease that can ultimately lead to irreversible fibrosis, scarring, and damage of the GI tract that can result in surgery for the majority of patients. The EXPLORER study will evaluate if the combination therapy can have an impact on these complications.

Participants may be eligible if they:

  • Are between 18 and 80 years of age at the time of screening for the study
  • Have been diagnosed with Crohn’s disease within 24 months prior to screening for the study
  • Currently have moderate to severely active Crohn’s disease at high risk for complications, which will be assessed during screening for the study*
  • Are able and willing to comply with the study visit schedule and instructions they are given

* The study doctor will discuss additional criteria for this clinical research study should you choose to participate.

WHAT HAPPENS IF I TAKE PART IN THE STUDY?

If eligible, you or your family member may participate in the open-label study. During this time, you will make regular visits to the study clinic (following the screening period). The EXPLORER clinical research study is a long-term* clinical research study that includes the screening period, which may be up to 4 weeks, followed by:

  • A 26-week period where you will take all 3 study drugs—vedolizumab, adalimumab, and oral methotrexate
  • An additional 76-week period where you will take only 1 of the study drugs—vedolizumab
  • A 26-week follow-up period following the last dose. You will return to the study site for one visit, and you will receive a phone call at the end of the follow-up period to answer a few questions.

You can expect to visit the clinic approximately 20 times over the 124-week period, depending on the scheduling of your study procedures.

*Total time of study involvement may be up to 132 weeks.

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